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NCT01615029 · ClinicalTrials.gov registry record · Phase 1
Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01615029: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01615029 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01615029, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).
Primary Outcome
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistoc
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Part 1 (Dose Escalation): Daratumumab
- DRUG Part 2 (Dose Expansion): Daratumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-06-26 |
| Est. Completion | 2024-10-23 |
| Phase | Phase 1 |
What the finished NCT01615029 record still lists
NCT01615029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT01615029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01615029 about?
NCT01615029 is a clinical study titled "Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma". The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).
What is the current status of trial NCT01615029?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2012-06-26. Estimated completion is 2024-10-23.
What interventions are being tested in trial NCT01615029?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Part 1 (Dose Escalation): Daratumumab (DRUG), Part 2 (Dose Expansion): Daratumumab (DRUG).
Who is sponsoring clinical trial NCT01615029?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01615029's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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